District Court Decisions – PharmaPatentshttps://www.pharmapatentsblog.com
Timely Insights On Emerging DevelopmentsTue, 18 Dec 2018 06:00:08 +0000en-UShourly1https://wordpress.org/?v=4.9.9https://pharmapatents.foleylardnerblogs.com/wp-content/uploads/sites/16/2018/04/cropped-foley-site-icon-32x32.pngDistrict Court Decisions – PharmaPatentshttps://www.pharmapatentsblog.com
3232District Court Finds PK Targets Of VIMOVO Patents Indefinitehttps://www.pharmapatentsblog.com/2018/11/27/district-court-finds-pk-targets-indefinite/
https://www.pharmapatentsblog.com/2018/11/27/district-court-finds-pk-targets-indefinite/#respondTue, 27 Nov 2018 06:00:12 +0000https://www.pharmapatentsblog.com/?p=7649
In an opinion issued November 19, 2018, Judge Chesler of the U.S. District Court for the District of New Jersey found two Orange Book-listed patents for VIMOVO® invalid for indefiniteness in the way certain pharmacokinetic (PK) properties were recited. The opinion supports the court’s summary judgement of invalidity of the patents. The VIMOVO® Patents At...… Continue reading this entry]]>

In an opinion issued November 19, 2018, Judge Chesler of the U.S. District Court for the District of New Jersey found two Orange Book-listed patents for VIMOVO® invalid for indefiniteness in the way certain pharmacokinetic (PK) properties were recited. The opinion supports the court’s summary judgement of invalidity of the patents.

The VIMOVO® Patents At Issue

The VIMOV® patents at issue in this decision were U.S. Patent Nos. 9,220,698 and 9,393,208, which claim methods of treating, e.g., osteoarthritis or rheumatoid arthritis, by administering “AM” and “PM” unit dose forms comprising naproxen and esomeprazole, wherein the AM and PM unit dose forms “target” certain pharmacokinetic profiles, such as certain Cmax, Tmax, and mean plasma concentration AUC levels.

Indefiniteness Of “Target” PK Values

The court first considered whether the “target” clauses were limiting or merely recited intended results of the claimed methods. On this issue, the court determined that the Applicant’s reliance on these features during examination to distinguish prior art required that they be given weight.

Turning to the indefiniteness issue, the court applied its construction of the term “target” as meaning “set as a goal,” and found the claims indefinite. Indeed, reading the opinion begs the question whether that claim construction doomed the claims from the outset.

The court reasoned:

The fundamental difficulty is that both key phrases here are incomprehensible: “the AM and PM unit dose forms target:” and “the AM and PM unit dose forms further target.” It is not possible to comprehend what these phrases mean, because pills cannot be said to set goals. In ordinary usage, we understand a goal to be something that people, or perhaps living creatures, set; inanimate objects set no goals.

According to Judge Chesler, because target” was construed to mean “set as a goal,” and because the claims recite that the dosage forms “target” the recited PK parameters, the claims are “incomprehensible” because dosage forms cannot set goals.

Even putting that particular conundrum aside, the court noted, “The problem here is that the target clauses fail to draw clear boundaries.” That is, the court could “see[] no way that defining the goals for a method can, without more, inform the public of how to act to avoid infringement.”

The court found that the Patentee’s arguments treated “target” as meaning “produce,” which was inconsistent with the claim construction and therefore unhelpful (or, in the court’s words, “defective”).

Thus, the court concluded that the claims, “read in light of the specification delineating the patents, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention,” and therefore are invalid as indefinite.

Why “Target” PK Values?

The “target” language at issue in this case is found in the original claims, and appears throughout the patent specifications without express definition or direct explanation. It is possible that this terminology was chosen with the knowledge that not every administration of the claimed AM and PM dose units would achieve the recited PK parameters in every patient. Unfortunately for the Patentees here, the court rejected their argument that “target” should be construed as “produce,” which also foreclosed their arguments that the recited PK parameters were average values obtained across a group of patients.

In parallel Inter Partes Review proceedings, the USPTO Patent Trial and Appeal Board constructed “target” as “have or set the goal of obtaining.” Would the “have” aspect of that construction left room for a different result here?

]]>https://www.pharmapatentsblog.com/2018/11/27/district-court-finds-pk-targets-indefinite/feed/0Are These INOMax Therapeutic Method Claims Directed To A Natural Phenomenon?https://www.pharmapatentsblog.com/2018/02/20/are-these-inomax-therapeutic-method-claims-directed-to-a-natural-phenomenon/
https://www.pharmapatentsblog.com/2018/02/20/are-these-inomax-therapeutic-method-claims-directed-to-a-natural-phenomenon/#respondTue, 20 Feb 2018 06:00:40 +0000https://www.pharmapatentsblog.com/?p=7381
In Mallinckrodt Hospital Prods. IP Ltd. v. Praxair Distrib., Inc., Judge Sleet of the U.S. District Court for the District of Delaware invalidated personalized method of treatment claims under 35 USC § 101 as being directed to a natural phenomenon. If the Federal Circuit affirms the decision, will it leave room to draw a line that...… Continue reading this entry]]>

In Mallinckrodt Hospital Prods. IP Ltd. v. Praxair Distrib., Inc., Judge Sleet of the U.S. District Court for the District of Delaware invalidated personalized method of treatment claims under 35 USC § 101 as being directed to a natural phenomenon. If the Federal Circuit affirms the decision, will it leave room to draw a line that spares other methods of treatment?

The INOMax® Patents At Issue

The underlying ANDA litigation involved a number of Orange Book-listed patents for INOMax®, a nitric oxide delivery system indicated for use to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in neonatal patients with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. Judge Sleet cited claim 1 of U.S. Patent No. 8,795,741 as representative:

1. A method of treating patients who are candidates for inhaled nitric oxide treatment, which method reduces the risk that inhalation of nitric oxide gas will induce an increase in pulmonary capillary wedge pressure (PCWP) leading to pulmonary edema in neonatal patients with hypoxic respiratory failure, the method comprising:
(a) identifying a plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment;
(b) determining that a first patient of the plurality does not have left ventricular dysfunction;
(c) determining that a second patient of the plurality has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide;
(d) administering 20 ppm inhaled nitric oxide treatment to the first patient; and
(e) excluding the second patient from treatment with inhaled nitric oxide, based on the determination that the second patient has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide.

The Patent Eligibility Analysis

As summarized in Judge Sleet’s memorandum opinion, the patent owner argued that the claims “disclose patent-eligible subject matter because they recite a new way to use an existing drug—administering iNO in such a way that neonates or children with LVD are at a reduced risk of pulmonary edema or other [adverse events].”

Conducting step 1 of the Mayo/Alice analytical framework, the district court determined:

[T]he core of the alleged invention is the increased risk of pulmonary-capillary wedge pressure that develops when administering iNO to term or near-term patients with both hypoxic respiratory failure and left-ventricular dysfunction. …. That “invention” is really a patient populations’ natural physiological response to 20 ppm of inhaled nitric oxide treatment. While man discovered the adverse physiological response that occurs when some patients receive iNO, such a discovery does not amount to innovation.

Conducting step 2 of the Mayo/Alice framework, the district court determined that all steps either were routine and conventional (steps (a), (b) and (d)) or did not transform the claim into patent-eligible subject matter (step (c). With regard to step (e), the court stated:

The natural phenomenon is that some patients with preexisting LVD have a negative reaction to treatment. Plaintiffs cannot seriously contend that it is a new practice to exclude certain patients from treatment with a drug when those patients are at an increased risk of experiencing negative side effects from the drug.

The court also found similarities between the claims at issue and those invalidated by the Supreme Court in Mayo and by the Federal Circuit in Cleveland Clinic.

The court concluded:

[T]he HF claims are not directed to a new way to use an existing drug. Instead, the claims are directed to a conventional response to the discovery of a serious adverse event. The method offers no innovation or improvement over the prior art outside of the novel realization that patients with LVD should not receive iNO treatment because their bodies respond to that treatment in a way that increases their risk of pulmonary edema. While that realization may be valuable, it is not worthy of patent protection.

What Will The CAFC Do?

Although the district court referred to the Federal Circuit decision in Cleveland Clinic, the claims invalidated in that case were diagnostic claims, not therapeutic method claims. While I would like to predict that the Federal Circuit would not invalidate a method of treatment claim under § 101, Judge Sleet’s analysis highlights the slippery slope presented by the “natural phenomenon” paradigm. The judge characterized the claimed invention as “a patient populations’ natural physiological response to 20 ppm of inhaled nitric oxide treatment.”—couldn’t the same be said about any therapeutic method of treatment?

Mallinckrodt’s appeal to the Federal Circuit is in the briefing stage, so it is possible the case could be decided this year.

]]>https://www.pharmapatentsblog.com/2018/02/20/are-these-inomax-therapeutic-method-claims-directed-to-a-natural-phenomenon/feed/0When Does An RCE Stop The PTA Clock?https://www.pharmapatentsblog.com/2018/02/13/when-does-an-rce-stop-the-pta-clock/
https://www.pharmapatentsblog.com/2018/02/13/when-does-an-rce-stop-the-pta-clock/#respondTue, 13 Feb 2018 06:00:58 +0000https://www.pharmapatentsblog.com/?p=7373
In Novartis v. Lee (Fed. Cir. 2014), the Federal Circuit agreed with the USPTO that “time spent in a continued examination” does not count towards the three years the USPTO is allotted to examine a patent before if it must award Patent Term Adjustment (PTA) for “B” delay. Under the USPTO’s rules, filing a Request for Continued Examination...… Continue reading this entry]]>

In Novartis v. Lee (Fed. Cir. 2014), the Federal Circuit agreed with the USPTO that “time spent in a continued examination” does not count towards the three years the USPTO is allotted to examine a patent before if it must award Patent Term Adjustment (PTA) for “B” delay. Under the USPTO’s rules, filing a Request for Continued Examination (RCE) stops that PTA clock, but in Ariad Pharmaceuticals, Inc. v. Matal, the U.S. District Court for the Eastern District of Virginia found that the clock should keep running when the USPTO mishandles an RCE. So, exactly when does an RCE stop the PTA clock?

The PTA Statute At Issue

The PTA statute at issue in this case is 35 USC § 154(b)(1)(B)(i), which provides:

(B) GUARANTEE OF NO MORE THAN 3-YEAR APPLICATION PENDENCY.- Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to the failure of the United States Patent and Trademark Office to issue a patent within 3 years after the actual filing date of the application in the United States, not including–(i) any time consumed by continued examination of the application requested by the applicant under section 132(b) ….

The USPTO’s interpretation of this provision is set forth in 37 CFR § 1.703(b)(1):

(b) The period of adjustment under § 1.702(b) is the number of days, if any, in the period beginning on the day after the date that is three years after the date on which the application was filed under 35 USC 111(a) or the national stage commenced under 35 USC 371(b) or (f) in an international application and ending on the date a patent was issued, but not including the sum of the following periods:(1) The number of days, if any, in the period beginning on the date on which a request for continued examination of the application under 35 USC 132(b) was and ending on the date of mailing of the notice of allowance under 35 USC 151 ….

Thus, under the USPTO’s rule, once an RCE is filed, the patent no longer accrues “B” delay, although it might still accrue “A” delay and/or “C” delay. (Please see this article for a more detailed discussion of this issue and the PTA framework.)

The Ariad Patent Prosecution History

The Ariad patent at issue is U.S. Patent No. 8, 114,874. During prosecution, Ariad filed an RCE, but the USPTO mishandled it and issued a Notice of Abandonment that took four months rescind:

(Excerpt from the PAIR Transaction History record for U.S. Patent No. 8, 114,874)

When the USPTO calculated PTA for the patent, it applied Rule 703(b)(i) and excluded the entire time from the mishandled RCE to the subsequent Notice of Allowance from its “B” delay calculation.

The PTA Issue On Appeal

Ariad appealed the USPTO’s PTA award to the U.S. District Court for the Eastern District of Virginia. The court summarized the issues presented as follows:

The PTO contends that “time consumed by continued examination” includes any time after the filing of an RCE, which occurred in February 2010, and as such, the time from February to June was properly excluded. ARIAD counters by arguing that time during which the PTO erroneously considered the application abandoned and therefore did not conduct continued examination should not be excluded and that this time should be credited to ARIAD as “B Delay.”

The district court (Judge Ellis, III) found that the plain language of the statute and the purpose of the statute supported Ariad’s position:

To begin with, it is important to note that Congress did not use the phrase—“time after the applicant filed a request for continued examination” … in the statutory text. Instead, Congress chose to draft the provision as “any time consumed by continued examination of the application requested by the applicant.”

Time cannot possibly be used in the course of continued examination where, as here, the PTO erroneously determines the application is abandoned and does not believe it has even received an RCE.

The court continued:

ARIAD’s interpretation of the statute also comports with the purpose of this statutory provision. The legislative history of the AIPA suggests that Congress intended the “B Delay” exclusions to include delay attributable to the applicant, and not to the PTO.

The delay here was indisputably attributable to the PTO; the delay was not the result of the applicant’s request for continued examination but rather the delay in question was the result of the PTO’s erroneous notice of abandonment.

The USPTO argued that under Ariad’s interpretation it would be too burdensome to identify and account for days of actual continued examination (e.g., days the examiner actually examined the application at issue), but the court did not require such a granular application of the statute:

If, as the statute suggests, “time consumed by continued examination” begins when the RCE is forwarded to the patent examiner, the PTO would not need to determine which days the patent examiner actually engaged in continued examination because the clock would begin to run as soon as the request was forwarded.

The court refused to give deference to the USPTO’s construction, either as being “contrary to the plain language of an unambiguous statute” or as a procedural rule not entitled to Chevron deference.

Thus, the court granted summary judgment in favor of Ariad.

When Does an RCE Stop the PTA Clock?

The district court’s decision seems fair on the facts presented. Why should Ariad be denied PTA for examination delays due to the USPTO’s errors? A question remains, however, as to whether the court’s decision invalidates Rule 703(b)(i) in all cases, or only “as applied to these facts.” Does the USPTO need to rewrite the rule to start the excluded time period on the date on which an application is forwarded to the examiner after an RCE has been filed? Or does it only need to account for a lack of post-RCE examination diligence when it mishandles an RCE?

Anecdotally, it appears that it typically may take a few days after an RCE is filed for an application to be forwarded to the examiner, at least according to Transaction History records on PAIR.

]]>https://www.pharmapatentsblog.com/2018/02/13/when-does-an-rce-stop-the-pta-clock/feed/0Biosimilar Remedies Not Limited Without Full Patent Dancehttps://www.pharmapatentsblog.com/2017/03/14/biosimilar-remedies-not-limited-without-patent-dance/
https://www.pharmapatentsblog.com/2017/03/14/biosimilar-remedies-not-limited-without-patent-dance/#respondTue, 14 Mar 2017 05:00:39 +0000https://www.pharmapatentsblog.com/?p=7089
The judge presiding over the pending biosimilar litigation between Janssen and Celltrion/Hospira has issued guidance regarding the ramifications of a potential standing defect. Judge Wolf opined that Janssen’s biosimilar remedies would not be limited to a reasonable royalty under 35 USC § 271(e)(6) if it turns out that Janssen lacks standing for failure to join...… Continue reading this entry]]>

The judge presiding over the pending biosimilar litigation between Janssen and Celltrion/Hospira has issued guidance regarding the ramifications of a potential standing defect. Judge Wolf opined that Janssen’s biosimilar remedies would notbe limited to a reasonable royalty under 35 USC § 271(e)(6) if it turns out that Janssen lacks standing for failure to join all owners of the patents-in-suit, and must file a new suit. He announced his guidance at hearings on February 23-24, and in a written Memorandum and Order issued March 2.

The Remicade® Biosimilar Litigation

As discussed in this article, Janssen initially sued Celltrion and Hospira in March 2015 for violations of the Biologics Price Competition and Innovation Act (BPCIA) relating to Celltrion and Hospira’s abbreviated Biologic License Application (aBLA) for infliximab (a proposed biosimilar version of Janssen’s Remicade® product). Janssen brought a second infringement action against Celltrion and Hospira in June 2016, alleging actual infringement after defendants commenced manufacture. Both cases are pending before Judge Wolf in the U.S. District Court for the District of Massachusetts. The cases were scheduled for trial on February 13, 2017, but the trial was postponed after defendants questioned Janssen’s standing.

Section 271(e)(6)’s Limitation On Biosimilar Remedies

Although standing can be cured by filing a new suit, Celltrion and Hospira argued that Janssen’s remedies in a new suit would be limited to a reasonable royalty under § 271(e)(6):

(6)
(A) Subparagraph (B) applies, in lieu of paragraph (4), in the case of a patent—
(i) that is identified, as applicable, in the list of patents described in section 351(l)(4) of the Public Health Service Act or the lists of patents described in section 351(l)(5)(B) of such Act with respect to a biological product; and
(ii) for which an action for infringement of the patent with respect to the biological product—
(I) was brought after the expiration of the 30-day period described in subparagraph (A) or (B), as applicable, of section 351(l)(6) of such Act; or
(II) was brought before the expiration of the 30-day period described in subclause (I), but which was dismissed without prejudice or was not prosecuted to judgment in good faith.

(B) In an action for infringement of a patent described in subparagraph (A), the sole and exclusive remedy that may be granted by a court, upon a finding that the making, using, offering to sell, selling, or importation into the United States of the biological product that is the subject of the action infringed the patent, shall be a reasonable royalty. ….

While the language of the statute is complicated, Celltrion and Hospira relied on the premise that a reasonable royalty is the only remedy for infringement when an infringement action is brought “after the expiration of the 30-day period described in subparagraph (A) or (B), as applicable, of [42 USC § 262(l)(6)].”

Was § 271(e)(6) Triggered?

35 USC § 271(e)(6) refers to the lists of patents described in §§ 351(l)(4) and 351(l)(5)(B) of the Public Health Service Act (codified at 42 U.S.C. §§ 262(l)(4) and 262(l)(5)(B)), which are the “patent lists” that culminate from the “patent dance” procedures of the BPCIA. According to Janssen, however, Celltrion refused to complete the “patent dance” by failing to provide information regarding its manufacturing process and attempting to “moot” certain steps of the dance by consenting to Janssen’s proposed patent list.

In his guidance to the parties, Judge Wolf found that a reasonable fact-finder could not conclude that Celltrion had completed the “patent dance” in good faith. As such, Janssen’s remedies in a new suit (if necessary) would notbe limited to a reasonable royalty under § 271(e)(6):

The court construes the term “shall” in §§262 (l)(4) and (5) to mean that the alleged infringer must comply with each step of the BPCIA process in order to limit the patentee to a reasonable royalty if it does not sue within 30 days of the end of that process. ….

It is only the list of patents that emerge from the properly completed BPCIA procedure that are potentially subject to the reasonable royalty damages limitation. On the present record, it could not be found that the six patents originally subject to litigation in this case emerged from a properly completed statutory process.

With this guidance, Judge Wolf ordered the parties to confer regarding the possibility of settlement by March 17.

]]>https://www.pharmapatentsblog.com/2017/03/14/biosimilar-remedies-not-limited-without-patent-dance/feed/0Will The Avastin Biosimilar Patent Dance Go On?https://www.pharmapatentsblog.com/2017/03/07/court-dismisses-avastin-biosimilar-complaint/
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Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but the Avastin biosimilar patent dance still may go on. Judge Sleet dismissed the complaint without prejudice and gave Genentech 45 days to amend its complaint....… Continue reading this entry]]>

Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but the Avastin biosimilar patent dance still may go on. Judge Sleet dismissed the complaint without prejudice and gave Genentech 45 days to amend its complaint. Perhaps more importantly, the clock still may be running against Genentech to make the next move in the patent dance.

Genentech’s Patent Dance Complaint

As explained in this article, this case arose from Amgen’s November 2016 aBLA for a biosimilar version of Genentech’s Avastin® (bevacizumab) product, which Genentech describes as it “best-selling cancer drug.” However, Genentech’s complaint was not for patent infringement, but rather alleged that Amgen failed to comply with the information exchange requirements of the “patent dance” provisions of the BPCIA. Although Amgen provided a copy of its aBLA to Genentech in accordance with 42 USC § 262(l)(2)(A), Genentech alleged that Amgen failed to provide additional required information, such as informaton regarding its manufacturing process.

Amgen’s Right To Sit This One Out

In a letter to the court dated February 27, 2017, Amgen argued that Genentech’s complaint should be dismissed as “procedurally improper” under the Federal Circuit decision in Amgen v. Sandoz. According to Amgen:

[That case] squarely holds that the sole and exclusive remedy for any alleged non-compliance with 42 U.S.C. 262(/)(2)(A) is a patent infringement action.

As explain in this article, the Federal Circuit ruled in Amgen v. Sandoz that if a biosimilar applicant fails to follow the “patent dance” procedures of 42 U.S.C. § 262(l)(2)(A), the only “remedy” available to the reference product sponsor is to pursue a patent infringement claim under 42 USC § 262(l)(9)(C) and 35 U.S.C § 271(e)(2)(C)(ii).

(Amgen acknowledged that it has asked the Supreme Court to reverse that decision, but noted that the decision “remains controlling authority here.”)

Since Genentech’s complaint did not assert any claims of patent infringement, Amgen argued that it was precluded under Amgen v. Sandoz.

Must Genentech Keep Dancing By Itself?

Genentech filed a responsive letter to the court dated February 28, 2017, arguing that Amgen v. Sandoz only applies when a biosimilar applicant opts out of the patent dance altogether. According to Genentech, because Amgen opted into the patent dance by providing a copy of its aBLA to Genentech, the court should have the authority to resolve this dispute so the patent dance can go on.

Genentech also argued that biosimilar applicants who opt into the patent dance benefit considerably because it imposes certain limitations on “how and when the innovator [reference product sponsor] can exercise its patent rights.” That also means that the reference product sponsor is at a disadvantage when the biosimilar applicant withholds information needed to assess patent infringement. For example, Genentech argues that it will be forced “either to produce a list of potentially infringed patents under § 262(l)(3)(A), without the full production of materials or expert assistance that should have informed that list, or sue Amgen for infringement and wait and see whether that lawsuit was proper at some later time.”

Is This Dance Over?

Judge Sleet dismissed Genentech’s complaint for lack of subject matter jurisdiction without prejudice, and gave Genentech the opportunity to filed an amended complaint within 45 days (i.e., April 15). However, according to its February 28 letter, Genentech faces a March 24, 2017 deadline for serving Amgen with its list of potentially infringed patents under § 262(l)(3)(A). It will be interesting to see whether Genentech continues on with the patent dance or opts out itself by filing a declaratory judgment action under 42 USC § 262(l)(9)(C) and 35 U.S.C § 271(e)(2)(C)(ii).

]]>https://www.pharmapatentsblog.com/2017/03/07/court-dismisses-avastin-biosimilar-complaint/feed/0District Court Dismisses USPTO December 2015 Holidays Casehttps://www.pharmapatentsblog.com/2016/12/20/district-court-dismisses-uspto-december-2015-holidays-case/
https://www.pharmapatentsblog.com/2016/12/20/district-court-dismisses-uspto-december-2015-holidays-case/#respondTue, 20 Dec 2016 06:00:19 +0000https://www.pharmapatentsblog.com/?p=6990
On December 2, 2016, Judge O’Grady of the U.S. District Court for the Eastern District of Virginia granted the USPTO’s motion to dismiss the complaint brought by Elm 3DS Innovations, LLC over the “holidays” declared December 22-24, 2015 when the USPTO experienced a power outage that impacted its electronic filing systems. The decision may leave other...… Continue reading this entry]]>

On December 2, 2016, Judge O’Grady of the U.S. District Court for the Eastern District of Virginia granted the USPTO’s motion to dismiss the complaint brought by Elm 3DS Innovations, LLC over the “holidays” declared December 22-24, 2015 when the USPTO experienced a power outage that impacted its electronic filing systems. The decision may leave other stakeholders wondering whether Elm was not the best party to challenge the USPTO’s action, or whether the action is simply unreviewable under the APA.

The December 2015 “Holidays”

On December 22, 2015, at approximately 7:00 pm, the United States Patent and Trademark Office (USPTO) experienced a major power outage at its headquarters in Alexandria, Virginia, resulting in damaged equipment that required the subsequent shutdown of many USPTO online and information technology systems. ….

On the same webpage, the USPTO explains the decision to treat December 22-24, 2015 as “Federal holiday[s] within the District of Colombia”:

In light of this emergency situation, the USPTO will consider each day from Tuesday, December 22, 2015, through Thursday, December 24, 2015, to be a “Federal holiday within the District of Columbia” under 35 U.S.C. § 21 and 37 C.F.R. §§ 1.6, 1.7, 1.9, 2.2(d), 2.195, and 2.196.

As a result, “[a]ny action or fee due on these days will be considered as timely for the purposes of, e.g., 15 U.S.C. §§ 1051(b), 1058, 1059, 1062(b), 1063, 1064, and 1126(d), or 35 U.S.C. §§ 119, 120, 133, and 151, if the action is taken, or the fee paid, on the next succeeding business day on which the USPTO is open (37 C.F.R. §§ 1.7(a) and 2.196).”

Elm’s Complaint

Elm challenged the USPTO’s authority to declare that a day was a “Federal holiday within the District of Colombia” when that day was not treated as such by any other Federal agency. In particular, Elm asserted that only Congress can declare a “Federal holiday within the District of Colombia.”

Elm asserted that it was harmed by these “holidays” because the PTAB accepted IPR petitions filed against its patents on December 28, 2015, even though the statutory deadline for the petitions expired December 24, 2015.

The District Court Decision

Judge O’Grady gave three main reasons for granting the USPTO’s motion to dismiss:

The declaration of holidays was not a “final agency action” reviewable under the APA, because it is “[a] merely procedural rule, which does not impose harm.”

Elm has an alternative remedy via appeal to the Federal Circuit once there has been a final decision in the IPR proceedings.

On the second point, the court noted that for purposes of APA review, “final agency action” has been defined as “action … by which rights or obligations have been determined, or from which legal consequences will flow.” The court found that none of Elm’s alleged injuries were “concrete and immediately felt” when the holidays were declared, but rather were “contingent on events independent of [the USPTO’s holiday] actions,” namely, those of the IPR petitioners and the PTAB. The court also stated that while the “holidays” changed the mechanism by which petitioners were permitted to file the IPRs, it did not expand their substantiverights. That is, because of the “holidays” petitioners could file their petitions electronically on December 28 instead of having to request permission to file by mail by December 24, but the substantive IPR requirements were not affected.

Is The USPTO’s Action Unreviewable?

If Elm’s patents are invalidated in the IPR proceedings, it may raise its claim against these “holidays” again in an appeal to the Federal Circuit. If so, it will be interesting to see whether the Federal Circuit will review this USPTO action, or will agree with the district court that it is unreviewable under the IPR statute and/or the APA. If the Federal Circuit renders a decision under the IPR statute, that could leave open the door for challenge by a party harmed in the ex parte context, such as a party who would have been a “first inventor to file” but for the acceptance of an application that took advantage of the additional time conferred by the “holidays,” or in the infringement context, such as a party accused of infringement of a patent that would be invalid but for the additional grace period provided by the “holidays.”

]]>https://www.pharmapatentsblog.com/2016/12/20/district-court-dismisses-uspto-december-2015-holidays-case/feed/0District Court Denies Extra Patent Term Adjustment When National Stage Entry Date Falls On A Holidayhttps://www.pharmapatentsblog.com/2016/10/27/district-court-denies-extra-patent-term-adjustment-when-national-stage-entry-date-falls-on-a-holiday/
https://www.pharmapatentsblog.com/2016/10/27/district-court-denies-extra-patent-term-adjustment-when-national-stage-entry-date-falls-on-a-holiday/#respondThu, 27 Oct 2016 05:00:46 +0000https://www.pharmapatentsblog.com/?p=6932
Some patent term adjustment (PTA) cases have broad impact–like Wyeth v. Kappos and Novartis v. Lee–but Acetelion Pharmaceuticals, Inc. v. Lee addresses a more esoteric issue: when does the 14-month clock start to run in a U.S. national stage application when the 30-month national stage entry days falls on a Federal holiday? Judge O’Grady of the...… Continue reading this entry]]>

Some patent term adjustment (PTA) cases have broad impact–like Wyeth v. Kappos and Novartis v. Lee–but Acetelion Pharmaceuticals, Inc. v. Lee addresses a more esoteric issue: when does the 14-month clock start to run in a U.S. national stage application when the 30-month national stage entry days falls on a Federal holiday? Judge O’Grady of the U.S. District Court for the Eastern District of Virginia agreed with the USPTO that the clock does not start to run until the next business day.

Type “A” Delay Under The PTA Statute

The PTA statute (35 USC § 154(b)) was created to compensate for delays in the patent examination process that can erode the effective term of a patent, which is measured from the patent’s earliest non-provisional U.S. priority date. The statute provides “guarantees” against different types of USPTO delays, and requires a day-for-day deduction of Applicant delays against USPTO delays.

The issue in Acetelion relates to “A” delay, which accrues when the USPTO fails to act in accordance with set time frames including failing to issue a “notification under section 132” (e.g., a Restriction Requirement or Office Action) within 14 months of “(I) the date on which an application was filed under section 111(a); or (II) the date of commencement of the national stage under section 371 in an international application.”

Starting The 14-Month Clock In U.S. National Stage Applications

Under the America Invents Act Technical Corrections Act (AIA TCA) (effective Jan. 14, 2013), the 14-month clock begins to run in a U.S. national stage application on “the date of commencement of the national stage.” Under the PCT, the national stage of examination will not commence until “expiration of 30 months from the priority date,” unless an applicant makes an “express request” for early examination. See PCT Article 23. In accordance with PCT rules, if “the expiration of any period” falls on an official holiday for the patent office at issue, then “the period shall expire on the next subsequent [business] day.” See PCT Rule 80.5.

The Acetelion National Stage Timeline

The patent at issue in Acetelion was granted from a U.S. national stage application filed January 12, 2012. According to the district court decision, the application was filed with “a Form PT0-1390 Transmittal Letter,” on which the applicant did notcheck the box indicating that the application was “an express request to begin national examination procedures.” However, the application also was filed with a Preliminary Amendment which included a statement that “Applicant earnestly solicits early examination and allowance of these claims. ….”

On January 26, 2012, the USPTO issued a Filing Receipt indicating receipt of the “35 U.S.C. §§ 375 (c)(l), (c)(2), and (c)(4) REQUIREMENTS” on January 12, 2012 and designating January 16, 2012 as the “DATE OF COMPLETION OF ALL 35 U.S.C. § 371 REQUIREMENTS[.]” However, January 16, 2012, was Martin Luther King, Jr. Day.Thus, when the USPTO calculated A delay for the patent, it started the 14-month clock on January 17, 2012.

Does The PCT Holiday Rule Impact PTA?

One of Acetelion’s arguments was that the USPTO abused its discretion when it started the the 14-month clock on January 17, 2012, instead of January 16, 2012. The USPTO justified this calculation based on PCT Rule 80.5, but Acetelion argued that the rule only should be invoked to help, not hurt, applicants:

[T]he weekend/holiday extension should only apply where a filer’s right would be protected by extending the deadline to the next business day whereas here, the length of Plaintiffs PTA and the rights associated with the increased patent term duration are constrained by the extension.

Acetelion also noted that the USPTO did not have to take any action in order for the 30 month period to expire, such that the timing of the holiday was irrelevant. The court rejected these arguments:

Because a filer can take actions on the expiration date, the PTO must be available to receive and take action on such filings–which is not possible on a weekend or federal holiday… Accordingly, [the USPTO’s] decision to apply the weekend/holiday exception is consistent with the interpretation of similar statutory provisions and is not a clear error of judgment.

The court therefore granted summary judgment in favor of the USPTO.

What About The Filing Receipt?

One dissatisfying aspect of this decision is the court’s failure to address the January 16, 2012 date listed on the Filing Receipt. Another dissatisfying aspect of this decision is the presumption that the USPTO must be able to “receive and take action” on the date submissions are made. Does the court think USPTO personnel review every document on the day it’s filed?

]]>https://www.pharmapatentsblog.com/2016/10/27/district-court-denies-extra-patent-term-adjustment-when-national-stage-entry-date-falls-on-a-holiday/feed/0Judge Grants Gilead Motion To Invalidate Remicade Patent For Obviousness-Type Double Patentinghttps://www.pharmapatentsblog.com/2016/10/05/judge-grants-gilead-motion-to-invalidate-remicade-patent/
https://www.pharmapatentsblog.com/2016/10/05/judge-grants-gilead-motion-to-invalidate-remicade-patent/#commentsWed, 05 Oct 2016 05:00:49 +0000https://www.pharmapatentsblog.com/?p=6902
The FDA approved Inflectra–Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product–in April 2016, but according to Pfizer’s press release it’s commercial launch still “depend[s] on a number of factors” including “intellectual property considerations.” The pending biosimilar patent litigation got one step closer to resolution last week when Judge Wolf of the U.S. District Court for the District of Massachusetts...… Continue reading this entry]]>

The FDA approved Inflectra–Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product–in April 2016, but according to Pfizer’s press release it’s commercial launch still “depend[s] on a number of factors” including “intellectual property considerations.” The pending biosimilar patent litigation got one step closer to resolution last week when Judge Wolf of the U.S. District Court for the District of Massachusetts granted Celltrion’s “Gilead Motion” for summary judgment of invalidity of U.S. Patent 6,284,471. The court entered final judgment on that patent to expedite Janssen’s ability to pursue an appeal and finally resolve at least that issue.

The Gilead Motion

As summarized in the court’s September 28, 2016 Memorandum and Order, Celltrion filed a motion for summary judgment of invalidity of the ‘471 patent based on obviousness-type double patenting in view of U.S. Patent 6,790,444. Since the ‘471 patent was granted before the ‘444 patent, the theory of obviousness-type double patenting was based on the Federal Circuit decision n Gilead. In that case, the court held that a patent that issues after but expires before another patent can qualify as a double patenting reference for that other patent.

The ‘471 patent is a pre-GATT patent filed February 4, 1994, and granted September 4, 2001. Its earliest priority claim is to U.S. Application 07/670,827, filed Mar. 18, 1991. Its 17-year term would expire September 4, 2018. The court characterized the ‘471 patent as covering a genus of compounds that includes infliximab.

The ‘444 patent is a post-GATTpatent that claims priority through several continuation-in-part applications to the application that granted as the ‘471 patent. Its earliest priority claim also is to U.S. Application 07/670,827, filed Mar. 18, 1991. Since the ‘444 patent is a post-GATT patent, its 20-year term expired in 2011. The court characterized the ‘444 patent as covering “the infliximab antibody specifically.”

Importantly, Janssen conceded that the claims of the ‘444 patent “are not patentably distinct” from the claims of the ‘471 patent. Thus, the only question before the court was whether the ‘444 patent could be cited as a double patenting reference.

Pre-GATT/Post-GATT

As the court noted, the issue presented by Celltrion’s Gilead Motion was factually distinct from the facts before the Federal Circuit in Gilead, because both patents at issue in Gilead were post-GATT patents. The court nevertheless determined that “the Federal Circuit would apply the Gilead ruling to the circumstances of this case.”

The court first noted that the URAA, which changed the basic patent term paradigm from 17 years from grant to 20 years from filing, did not address the scenario at issue:

The URAA is silent on this issue. It does not state that pre-URAA patents will always have 17 years’ protection. Nor does it reference the doctrine of obviousness-type double patenting.

The court then emphasized the policy concerns behind the doctrine, and found that they would be violated if the ‘471 patent was permitted to extend beyond the term of the ‘444 patent:

If plaintiffs’ position were correct, the public would be prevented from practicing the expired ‘444 patent and an obvious, patentably indistinct variation of it. This would violate the “bedrock principle . . . that when a patent expires, the public is free to use not only the same invention claimed in the expired patent but also obvious or patentably indistinct modifications of that invention,” … which is at the heart of the obviousness-type double patenting doctrine and which the Federal Circuit has found to be unaltered by the URAA.

Thus, the court determined that the ‘444 patent is citable as an obviousness-type double patenting reference against the ‘471 patent. In view of Celltrion’s concession that the claims were not patentably distinct, the court held that the challenged claims of the ‘471 patent are invalid for obviousness-type double patenting.

Duly Warned

In a section of his opinion that may make stakeholders cringe, Judge Wolf expressed no sympathy for Celltrion:

The obviousness-type double patenting doctrine was well-established when plaintiff applied for and when it accepted the ‘444 patent, which it knew would expire in 2011. Plaintiffs decided to take at least the risk that the ‘471 would be deemed invalid when the ‘444 expired.

Did Celltrion know in 2004 that in 2014 the Federal Circuit would hold that a later-granted patent could be cited against an earlier-granted patent?

]]>https://www.pharmapatentsblog.com/2016/10/05/judge-grants-gilead-motion-to-invalidate-remicade-patent/feed/1Apotex Biosimilar Cleared Of Infringement But Pre-Marketing Notice Still Requiredhttps://www.pharmapatentsblog.com/2016/09/15/district-court-clears-of-infringement/
https://www.pharmapatentsblog.com/2016/09/15/district-court-clears-of-infringement/#respondThu, 15 Sep 2016 05:00:00 +0000https://www.pharmapatentsblog.com/?p=6885
In what may be the first decision on the merits in a patent infringement suit brought under the Biologics Price Competition and Innovation Act (BPCIA), the U.S. District Court for Southern District of Florida has found that the method of making the Apotex biosimilar versions of Amgen’s Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) products does not infringe the asserted...… Continue reading this entry]]>

In what may be the first decision on the merits in a patent infringement suit brought under the Biologics Price Competition and Innovation Act (BPCIA), the U.S. District Court for Southern District of Florida has found that the method of making the Apotex biosimilar versions of Amgen’s Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) products does not infringe the asserted Amgen patent. Nevertheless, the court enjoined Apotex from entering the market until 180 days after it gives Amgen notice of commercial marketing once its biosimilar products are approved.

The Amgen Patent At Issue

As discussed in this article, after Apotex filed its biosimilar applications, Amgen and Apotex followed the patent dance provisions of the BPCIA, and Amgen’s U.S. Patent No. 8,952,138 was selected for litigation.

The ‘138 patent relates to a method of refolding a protein expressed in a non-mammalian expression system, a process that often is necessary to obtain proteins with the correct three-dimensional structure from a preparation that contains “inclusion bodies” of misfolded proteins. Refolding methods typically involve the use of mixtures of reducing agents, denaturants, and aggregation inhibitors under specific pH and redox potentials. Independent claim 1 of the ‘138 patent recites:

1. A method of refolding a protein expressed in a non-mammalian expression system and present in a volume at a concentration of 2.0 g/L or greater comprising: (a) contacting the protein with a refold buffer comprising a redox component comprising a final thiol-pair ratio having a range of 0.001 to 100 and a redox buffer strength of 2 mM or greater and one or more of: (i) a denaturant; (ii) an aggregation suppressor; and (iii) a protein stabilizer; to form a refold mixture; (b) incubating the refold mixture; and (c) isolating the protein from the refold mixture.

Apotex’s Biosimilar Applications

Apotex filed abbreviated Biologics License Applications (aBLA) Nos. 761026 and 761027 seeking FDA approval of biosimilar versions of Amgen’s Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) products. According to the district court decision, Apotex’s protein refolding process involves solubilizing 144-216 grams of inclusion bodies in 7.2 L of solubilization buffer to which is added dithiothreitol (DTT), which in turn is added dropwise into 160 L of refolding buffer without redox components. Oxidant, reductant, and oxidant are then added stepwise as illustrated below.

‘138 Patent Not Infringed

In a bench trial, the U.S. District Court for the Southern District of Florida found that Apotex’s method did not infringe the ‘138 patent.

The court had construed clause (a) of claim 1 as resulting in the formation of a “refold mixture” with a “high protein concentration” of 1.0 g/L or greater. The court determined that Apotex’s refold mixture did not have that much protein. In this regard, the court noted that the aBLAs specified a total protein limit of 0.708g/L and, in 91 batches, 0.56 g/L was the highest total protein concentration in the refold buffer.

The court had construed clause (a) as reciting a “redox buffer strength” of between 2 mM and 100 mM, noting that the upper limit was required because of solubility issues. Amgen had asserted that this aspect of the claims was infringed under the doctrine of equivalents, but the court disagreed. In particular, the court found that Apotex used a smaller volume of more concentrated redox components, and that Amgen had failed to show that methodology was equivalent to the claimed methodology.

Permanent Injunction Against Apotex

Notwithstanding its finding of no infringement, the court entered a permanent injunction against Apotex under the pre-marketing notice provisions of the BPCIA (42 U.S.C. § 262(1)(8)(A)):

Apotex must provide Amgen with at least 180 days’ notice before the date of the first commercial marketing of the biological product approved by the FDA. 42 U.S.C. § 262(1)(8)(A). Apotex and those acting in concert with it are enjoined from any commercial marketing of Apotex’s Filgrastim [or Pegfilgrastim] Product, including selling that product or offering it for sale for use in the United States, until Apotex gives Amgen proper notice, at least 180 days before first commercial marketing but not before Apotex’s Filgrastim [or Pegfilgrastim] Product is licensed by the FDA, and the 180-day notice period is exhausted.

Inter Partes Review Of The ‘138 Patent

Apotex filed a petition for Inter Partes Review of the ‘138 patent that was accorded a filing date on August 25, 2016. Amgen likely will defend the patent, and unless Amgen and Apotex settle their dispute over filgrastim and pegfilgrastim, Apotex likely still will want to invalidate the patent.

Other Neupogen® Biosimilar Litigation

Sandoz’s Zarxio® (filgrastim-sndz) product was the first biosimilar product approved by the FDA, and has been on the market since September 2015. Amgen has asserted U.S. Patent No. 6,162, 427 and U.S. Patent No.8,940,878 against Sandoz in litigation pending in the U.S. District Court for the Northern District of California.

]]>https://www.pharmapatentsblog.com/2016/09/15/district-court-clears-of-infringement/feed/0Magistrate Judge Nixes TB Test Kit Claimshttps://www.pharmapatentsblog.com/2016/09/13/6879/
https://www.pharmapatentsblog.com/2016/09/13/6879/#respondTue, 13 Sep 2016 05:00:50 +0000https://www.pharmapatentsblog.com/?p=6879
In a “Report and Recommendation on Defendants’ Joint Motion To Dismiss,” U.S. Magistrate Judge Cabell of the U.S. District Court for the District of Massachusetts determined that TB test kit claims do not satisfy the patent eligibility requirement of 35 USC § 101, but declined to reach the same conclusion with regard to related method claims. The decision...… Continue reading this entry]]>

In a “Report and Recommendation on Defendants’ Joint Motion To Dismiss,” U.S. Magistrate Judge Cabell of the U.S. District Court for the District of Massachusetts determined that TB test kit claims do not satisfy the patent eligibility requirement of 35 USC § 101, but declined to reach the same conclusion with regard to related method claims. The decision was issued in Oxford Immunotec Ltd. v. Qiagen, Inc., where Oxford has asserted that Qiagen’s test kits for diagnosing TB infection in vitro infringe a number of its patents.

17. A kit for in vitro diagnosis which distinguishes between (a) exposure of a human host to Mycobacterium tuberculosis and (b) vaccination of the human host with BCG, comprising a peptide panel, wherein the peptide panel comprises peptide SEQ. ID. No: 1.

The Magistrate Judge found the kit claims to be ineligible despite the ability of the recited peptides to “perform differently than peptides contained in an intact ESAT-6 strand” and despite the fact that the recited peptides are “synthetically created.” Citing Myriad, the Magistrate Judge focused on the fact that it was “undisputed that the peptides have not been changed beyond the act of isolation.” As such, “the isolated peptides are products of nature.”

The TB Test Method Claims At Issue

Three TB test method claims from three different patents were at issue:

1. A method of in vitro diagnosis of Mycobacterium tuberculosis infection in a host, comprising (a) keeping a population of T cells isolated from said host in contact with a peptide panel comprising one or more epitopes contained within peptide SEQ ID NO: 1, and (b) detecting a recognition response by the T cells to the peptide panel.

6. An assay for identifying Mycobacterium tuberculosis-specific immediate effector T cells in a subject, comprising: (a) providing a sample from said subject containing T cells; (b) exposing said T cells to an immunogenic amount of a peptide subfragment of ESAT-6 that contains a CD8+ epitope; (c) incubating said T cells for a period of time which is not sufficient to effect differentiation of quiescent T cells to immediate effector T cells; and (d) determining whether said T cells are activated by said peptide subfragment by measuring secretion of a cytokine from said T cells, wherein activation of said T cells identifies the presence of Mycobacterium tuberculosis-specific immediate effector T cells in said subject.

The Magistrate Judge found that the method claims relate to a law of nature: “which specific peptides in ESAT-6 are most likely to induce a recognition response by the T-cells of patients who have TB without creating false positive responses by the T-cells of those who have merely been vaccinated.” Nevertheless, the Magistrate Judge determined–at least for this preliminary stage–that “the patented invention improves on existing methods for diagnosing TB by making diagnosis more convenient, less dependent on a physician’s subjective interpretation of results, and more accurate,” and so could be patent-eligible.

The Magistrate Judge summarized his findings as follows:

At this early juncture, the Court concludes that the in vitro aspect of the plaintiff’s tuberculosis test is an “inventive concept” because it improves on prior methods of detecting tuberculosis infection. It follows that the method claims, which describe the in vitro test, are potentiallydrawn to patentable subject matter. In contrast, the kit claims only describe the peptide panel itself and do not involve the “inventive concept” of an in vitro test, and thus are not drawn to patentable subject matter.